510(k) K171019

ScioCardio ECG Transmitter by Synergen Technology Labs, LLC — Product Code DRG

K171019 is an FDA 510(k) premarket notification submitted by Synergen Technology Labs, LLC for the device "ScioCardio ECG Transmitter". The FDA issued a decision of Substantially Equivalent on May 30, 2018. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Synergen Technology Labs, LLC has at least 1 other 510(k) clearance on record.